PreDiabetesBEGINNCT04869917
Behavioral Nudges for Diabetes Prevention (BEGIN) Trial in Primary Care
A study testing Decision Aid intervention and Text Messaging intervention in people with PreDiabetes, run by Northwestern University at 1 site in United States.
Trial summary
A large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Decision Aid intervention and Text Messaging intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 960 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients (aged 18-80 years)
- with prediabetes
- overweight/obesity (BMI ≥25kg/m2)
- patients who speak English or Spanish
Who cannot join
- type 2 diabetes
- dementia
- serum creatinine >1.4mg/dL in women and >1.5mg/dL in men
- current use of oral corticosteroids
- current pregnancy
- uncontrolled hypertension (≥180/100mmHg)
- history of metformin use
- no office visits during the last 12 months
Trial locations and contacts
1 site in 1 country.
About this study
A large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. The Behavioral Nudges for Diabetes Prevention (BEGIN) Trial will test two low-touch interventions designed to motivate adoption of these treatments to prevent diabetes. Given that 38% of U.S. adults have prediabetes, the proposed study has potential for large public health impact by testing pragmatic, scalable, and sustainable approaches based in primary care to promote evidence-based treatment for this common condition.
Read the detailed description
Large randomized trials have found that intensive lifestyle interventions (ILI) and metformin are safe and effective treatment options for promoting modest weight loss and preventing type 2 diabetes (T2D) among adults with prediabetes. However, these treatments are rarely used in practice, and little existing research has focused on patient-centered approaches for promoting their use. One potential approach, behavioral nudges, involves manipulating health messages and treatment options to make behavior change more likely and easier to enact. While a large body of evidence suggests that behavioral nudges are effective, they have not been definitively studied for T2D prevention. The study team will address this critical knowledge gap by conducting the Behavioral Nudges for Diabetes Prevention (BEGIN) Trial. The proposed study will take place in primary care clinics, whose unprecedented reach and regular interaction with prediabetic adults make this an ideal setting for translational T2D prevention research. This definitive study will test two low-touch interventions: 1) prediabetes decision aid intervention consisting of a prediabetes decision aid designed to nudge uptake of evidence-based treatments and delivered by health educators; and 2) text messaging intervention consisting of text messages that deliver similar information and use the same behavioral nudges. The proposed R18 study will accomplish the following specific aims to determine the most effective low-touch intervention that promotes maximal treatment adoption and weight loss.
- Conditions
- PreDiabetes
- Being tested
- Decision Aid intervention, Text Messaging intervention, Usual Care
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Aid interventionBehavioural
- Displays information about the benefits and risks of ILI and metformin
- Asks open-ended questions: "What am I willing to do to prevent T2D?" and "What do I need to prevent T2D?"
- Prompts patients to commit to immediate next steps
- Health educator schedules interested patients for first ILI session or sends message to provider about patients' interest in starting metformin, if chosen
Text Messaging interventionBehavioural
- Defines prediabetes and includes individualized A1c values
- Present benefits and risks of intensive lifestyle intervention and metformin
- States that other prediabetic Erie patients are adopting intensive lifestyle intervention and metformin
- Encourages initiating intensive lifestyle intervention or discussing metformin with provider
- Include selected behavioral content from diabetes prevention program
- Initial message with automatic opt-in, allows opt-out for messages
- Subsequent messages include: information about T2D risk and treatments; prompts to directly schedule intensive lifestyle intervention or office visit to discuss metformin; selected behavioral content from diabetes prevention programming
Usual CareBehavioural
Patients receiving care at non-intervention clinic sites will not be exposed to treatment intervention.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid intervention | Experimental | Health Educators (HEs) will meet briefly with eligible participants after each office visit to review a prediabetes decision aid which reviews information about the benefits and risks of intensive lifestyle intervention and metformin. Receives: Behavioral: Decision Aid intervention |
| Text Messaging intervention | Experimental | Participants will receive biweekly messages throughout the 12-month trial. Automated messages will be sent using an existing secure text messaging platform. Receives: Behavioral: Text Messaging intervention |
| Decision Aid intervention + Text Messaging intervention | Experimental | Health Educators (HEs) will meet briefly with eligible participants after each office visit to review a prediabetes decision aid. Additionally, participants will receive biweekly messages throughout the 12-month trial. Automated messages will be sent using an existing secure text messaging platform. Receives: Behavioral: Decision Aid intervention; Behavioral: Text Messaging intervention |
| Usual Care | Placebo comparator | Usual care includes no additional intervention above the care routinely provided at the clinical partner site, Erie Family Health Center. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Mean differences in weight (lbs) between treatment arms will be evaluated using mixed models adjusted for clinic site, time between visits, sex, age, race/ethnicity, and baseline cardiometabolic markers
Measured: 12 months
Secondary outcomes (1)
Participant initiation of treatment to intensive lifestyle (ILI) or Metformin
The number of participants that initiate ILI, Metformin, or both treatments at follow-up which will be assessed in the following ways. Because initiation of metformin requires a provider prescription, this will be assessed pragmatically using the electronic health record (EHR) and confirmed by participant self-report of taking at least 1 dose. Attendance logs will be used to confirm whether participants attended at least 1 ILI session. Those who received a prescription for metformin but do not take any doses will not be considered to have initiated treatment. Similarly, those who are referred to ILI but do not attend any sessions will not be classified as initiating treatment. Receiving a provider's prescription for metformin or referral for ILI without initiating treatment will be an exploratory outcome.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start21 Mar 2022
- Primary completion1 Sep 2025
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study will utilize a 2x2 factorial design to test the effectiveness of the two proposed interventions on outcomes. Each of the participating clinical sites will be randomized to one of 4 treatment conditions. Employing a full factorial design, the participating clinics sites will be randomized to 1 of the following 4 treatment conditions: a) prediabetes decision aid intervention alone; b) text messaging intervention alone; c) both interventions; and d) usual care \[i.e. neither intervention\].
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew J O'Brien, Northwestern University
- Investigators
- Matthew J O'Brien, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869917
- Sponsor's protocol ID
- STU00212461
- Acronym
- BEGIN
- Status last verified
- Oct 2025
- First submitted
- 28 Apr 2021
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vargas MC, Pineda GJ, Talamantes V, Toledo MJL, Owen A, Carcamo P, Gibbert W, Ackermann RT, Kandula NR, Cameron KA, Siddique J, Williams GC, O'Brien MJ. Design and rationale of behavioral nudges for diabetes prevention (BEGIN): A pragmatic, cluster randomized trial of text messaging and a decision aid intervention for primary care patients with prediabetes. Contemp Clin Trials. 2023 Jul;130:107216. doi: 10.1016/j.cct.2023.107216. Epub 2023 May 9.
PubMed 37169219
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Nudges for Diabetes Prevention (BEGIN) Trial in Primary Care
- ClinicalTrials.gov ID
- NCT04869917
- Acronym / sponsor ID
- BEGIN / STU00212461
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. The Behavioral Nudges for Diabetes Prevention (BEGIN) Trial will test two low-touch interventions designed to motivate adoption of these treatments to prevent diabetes. Given that 38% of U.S. adults have prediabetes, the proposed study has potential for large public health impact by testing pragmatic, scalable, and sustainable approaches based in primary care to promote evidence-based treatment for this common condition.
Detailed description
Large randomized trials have found that intensive lifestyle interventions (ILI) and metformin are safe and effective treatment options for promoting modest weight loss and preventing type 2 diabetes (T2D) among adults with prediabetes. However, these treatments are rarely used in practice, and little existing research has focused on patient-centered approaches for promoting their use. One potential approach, behavioral nudges, involves manipulating health messages and treatment options to make behavior change more likely and easier to enact. While a large body of evidence suggests that behavioral nudges are effective, they have not been definitively studied for T2D prevention. The study team will address this critical knowledge gap by conducting the Behavioral Nudges for Diabetes Prevention (BEGIN) Trial. The proposed study will take place in primary care clinics, whose unprecedented reach and regular interaction with prediabetic adults make this an ideal setting for translational T2D prevention research. This definitive study will test two low-touch interventions: 1) prediabetes decision aid intervention consisting of a prediabetes decision aid designed to nudge uptake of evidence-based treatments and delivered by health educators; and 2) text messaging intervention consisting of text messages that deliver similar information and use the same behavioral nudges. The proposed R18 study will accomplish the following specific aims to determine the most effective low-touch intervention that promotes maximal treatment adoption and weight loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This study will utilize a 2x2 factorial design to test the effectiveness of the two proposed interventions on outcomes. Each of the participating clinical sites will be randomized to one of 4 treatment conditions. Employing a full factorial design, the participating clinics sites will be randomized to 1 of the following 4 treatment conditions: a) prediabetes decision aid intervention alone; b) text messaging intervention alone; c) both interventions; and d) usual care [i.e. neither intervention].
| Arm | Type | Receives |
|---|---|---|
| Decision Aid intervention | Experimental | Behavioral: Decision Aid interventionHealth Educators (HEs) will meet briefly with eligible participants after each office visit to review a prediabetes decision aid which reviews information about the benefits and risks of intensive lifestyle intervention and metformin. |
| Text Messaging intervention | Experimental | Behavioral: Text Messaging interventionParticipants will receive biweekly messages throughout the 12-month trial. Automated messages will be sent using an existing secure text messaging platform. |
| Decision Aid intervention + Text Messaging intervention | Experimental | Behavioral: Decision Aid intervention, Behavioral: Text Messaging interventionHealth Educators (HEs) will meet briefly with eligible participants after each office visit to review a prediabetes decision aid. Additionally, participants will receive biweekly messages throughout the 12-month trial. Automated messages will be sent using an existing secure text messaging platform. |
| Usual Care | Placebo comparator | Behavioral: Usual CareUsual care includes no additional intervention above the care routinely provided at the clinical partner site, Erie Family Health Center. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients (aged 18-80 years)
- with prediabetes
- overweight/obesity (BMI ≥25kg/m2)
- patients who speak English or Spanish
Key exclusion criteria (8 listed)
- type 2 diabetes
- dementia
- serum creatinine >1.4mg/dL in women and >1.5mg/dL in men
- current use of oral corticosteroids
- current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision Aid intervention* Displays information about the benefits and risks of ILI and metformin * Asks open-ended questions: "What am I willing to do to prevent T2D?" and "What do I need to prevent T2D?" * Prompts patients to commit to immediate next steps * Health educator schedules interested patients for first ILI session or sends message to provider about patients' interest in starting metformin, if chosen | Behavioural | Decision Aid intervention, Decision Aid intervention + Text Messaging intervention |
| Text Messaging intervention* Defines prediabetes and includes individualized A1c values * Present benefits and risks of intensive lifestyle intervention and metformin * States that other prediabetic Erie patients are adopting intensive lifestyle intervention and metformin * Encourages initiating intensive lifestyle intervention or discussing metformin with provider * Include selected behavioral content from diabetes prevention program * Initial message with automatic opt-in, allows opt-out for messages * Subsequent messages include: information about T2D risk and treatments; prompts to directly schedule intensive lifestyle intervention or office visit to discuss metformin; selected behavioral content from diabetes prevention programming | Behavioural | Decision Aid intervention + Text Messaging intervention, Text Messaging intervention |
| Usual CarePatients receiving care at non-intervention clinic sites will not be exposed to treatment intervention. | Behavioural | Usual Care |
Primary outcome
Weight
Time frame: 12 months
Mean differences in weight (lbs) between treatment arms will be evaluated using mixed models adjusted for clinic site, time between visits, sex, age, race/ethnicity, and baseline cardiometabolic markers
1 secondary outcome
Participant initiation of treatment to intensive lifestyle (ILI) or Metformin
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Derived from this study: PubMed 37169219Vargas MC, Pineda GJ, Talamantes V, Toledo MJL, Owen A, Carcamo P, Gibbert W, Ackermann RT, Kandula NR, Cameron KA, Siddique J, Williams GC, O'Brien MJ. Design and rationale of behavioral nudges for diabetes prevention (BEGIN): A pragmatic, cluster randomized trial of text messaging and a decision aid intervention for primary care patients with prediabetes. Contemp Clin Trials. 2023 Jul;130:107216. doi: 10.1016/j.cct.2023.107216. Epub 2023 May 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J O'Brien, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid intervention and Text Messaging intervention in people with PreDiabetes, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04869917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.